Novella Clinical, Inc. "formerly known as PharmaLinkFHI"
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Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Employees
Drug Safety Alliance Ashfield Pharmacovigilance May 2015 - Present
PPD December 2014 - April 2015
Theorem Clinical Research August 2014 - November 2014
Drug Safety Alliance, Inc. October 2013 - August 2014
Duke University Medical Center - Duke Cancer Institute December 2012 - March 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - June 2012
Independent Contractor August 2010 - November 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2009 - February 2010
Health Decisions April 2008 - December 2008
Skills
Drug Safety, Clinical Monitoring, CRO, Clinical Trials, EDC, GCP, Inform, Oncology, FDA, Clinical Research, Protocol, Data Management, SOP, MedDRA, CTMS
Education
North Carolina Agricultural and Technical State University 1989 — 1995
Bachelor of Science (B.Sc.), Food Science
Wincere, Inc as Gilead Contractor October 2013 - March 2014
Array BioPharma August 2011 - August 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" September 2010 - July 2011
INC Research July 2009 - September 2010
Allos Therapeutics, Inc July 2008 - July 2009
etrials Worldwide, Inc 2007 - 2008
INC Research 2005 - 2007
Skills
EDC, CRO, Clinical Trials, Clinical Data Management, 21 CFR Part 11, Oncology, GCP, CRF design, Oracle Clinical, Clinical Research, ICH-GCP, CTMS, Data Management, Clinical Development, Medidata, FDA, Protocol, Hematology, Validation, MedDRA, Inform
Education
University of North Carolina at Chapel Hill 1995 — 1999
Bachelor of Science in Biology
Novella Clinical November 2013 - Present
Novella Clinical, Inc. July 2009 - October 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2008 - July 2009
Accentuate Staffing June 2006 - June 2008
Ruthi Postow Staffing June 2005 - June 2006
Skills
CRO, CTMS, EDC, Clinical Trials, Clinical Research, Training, GCP, Human Resources, Pharmaceutical Industry, Clinical Development, ICH-GCP, Sop, Clinical Monitoring, Clinical Data Management, Software Documentation, Management, Oncology, SOP
Education
University of North Carolina at Chapel Hill 2001 — 2005
BA, Communication Studies
North Mecklenburg High School 1998 — 2001
Chimerix, Inc. April 2015 - Present
Salix Pharmaceuticals June 2012 - April 2015
Novella Clinical, Inc. December 2011 - July 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2009 - December 2011
PAREXEL 2008 - 2009
Duke Clinical Research Institute October 2004 - December 2008
Duke University Medical Center 2001 - 2004
Skills
Clinical Research
Education
Duquesne University 1994 — 1998
BSN, Nursing
Amerigroup August 2014 - August 2015
Quintiles October 2011 - August 2014
Vistronix, Inc. October 2010 - October 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2010 - August 2010
I3 United Healthcare June 2009 - December 2009
Novartis Animal Health May 2007 - June 2009
Syngenta Biotechnology, Research July 2005 - May 2007
Eli Lilly, Research July 2001 - December 2004
Amplistar Inc January 2001 - April 2001
Wyeth Pharmaceutical November 2000 - December 2000
Skills
Validation, SOP, Data Analysis, SQL, Problem Solving, Quality Assurance, Documentation, Clinical, GLP, Research, Databases, Biotechnology, Windows, Pharmaceuticals, Sop, GCP, Software Documentation, Regulatory Affairs, Clinical Development, FDA, Clinical Trials, GMP, LIMS, CTMS, Process Improvement, Pharmaceutical Industry
Education
Drexel University 2010 — 2012
MBA, Pharmaceutical Business
North Carolina Central University 2003 — 2006
Master, Information Systems
University of North Carolina at Chapel Hill 2002 — 2003
Business/MIS
Winston-Salem State University 1994 — 1996
BS, Applied Science
Appalachian State University
BIOLOGY, BUSINESS
North Carolina Agricultural and Technical State University
Array BioPharma July 2010 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2010 - June 2010
OSI Pharmaceuticals March 2009 - January 2010
OSI Pharmaceuticals January 2001 - March 2009
Gilead Sciences September 2000 - December 2001
Marion Laboratories 1987 - 1999
Skills
Oncology, Medicine, Clinical Trials, Clinical Development, CRO, Pharmaceutical Industry, Hematology, Drug Development, Clinical Research, Biotechnology, GCP, CTMS, Therapeutic Areas, EDC, Clinical Monitoring, Pharmacology, Clinical Data Management, Regulatory Submissions, Infectious Diseases, Medical Writing, ICH-GCP, Protocol, Regulatory Affairs, Immunology, Cancer, Sop, Clinical Operations, FDA, Medical Affairs, Drug Discovery, Clinical Pharmacology, Biomarkers, IND, Translational Medicine, Lifesciences, Pharmacokinetics, Pharmacovigilance, Biopharmaceuticals, Diabetes, GLP, Cardiology, Endocrinology, Pharmacodynamics, Phase I, Clinical Study Design, Neurology, Toxicology, Vaccines, Drug Metabolism
Education
The University of Kansas 1991 — 1993
MSN, Oncology Nursing
University of Kansas 1972 — 1977
MS, Oncology Nursing
PRA International October 2012 - Present
Novella Clinical, Inc. February 2008 - October 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" November 2007 - February 2008
PPD April 2006 - November 2007
PPD April 2005 - April 2006
PPD March 2004 - April 2005
PPD June 1999 - November 2002
Skills
Clinical Data Management, CRO, EDC, Clinical Monitoring, CTMS, Clinical Research, GCP
Education
Campbell University 2000 — 2003
BBA, Business
Acer Pharmaceutical Group 2011 - Present
PSI Pharma Support Intl 2010 - 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2010 - April 2011
i3 Research May 2009 - July 2010
Alpharma 2006 - 2009
Skills
Biotechnology, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, EDC, FDA, GCP, ICH-GCP, Lifesciences, Management, Medical Devices, Oncology, Pharmaceutical Industry, Project Management, Quality Assurance, Sop, Therapeutic Areas, Life Sciences
Education
Pfeiffer University 2007 — 2010
MBA/MHA
North Carolina State University 1996 — 2000
Novella Clinical, Inc. January 2013 - Present
Novella Clinical, Inc. April 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2006 - April 2007
Lineberger Comprehensive Cancer Center UNC Oncology Protocol Office October 2002 - February 2006
UNC Hospitals October 2000 - October 2002
Skills
Oncology, Inform, Cardiology, Diabetes, EDC, CTMS, Medical Devices, Clinical Research, Clinical Monitoring, FDA, Clinical Trials, CRO, GCP, Protocol, Software Documentation, Sop, CRF design, Trial Management, Clinical Data Management, Clinical Study Design, ICH-GCP, Therapeutic Areas, SOP
Education
Iona College 1989 — 1991
LPN, Nursing
Novella Clinical, Inc. August 2014 - Present
Novella Clinical Resourcing January 2008 - August 2014
Novella Clinical Inc. June 2006 - January 2008
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" March 2005 - March 2007
Novella Clinical Inc. April 2004 - March 2005
Skills
CRO, GCP, EDC, Oncology, Pharmaceutical Industry, Clinical Trials, Quality Assurance, Clinical Development, Clinical Monitoring, Regulatory Affairs, CTMS, ICH-GCP, Clinical Data Management, Sop, Regulatory Submissions, FDA, Clinical Operations, Therapeutic Areas, SOP
Education
National Paralegal College 2011 — 2013
Certificate in Paralegal Studies, Paralegal Studies
Michigan State University 1989 — 1991
Chiltern International August 2013 - Present
INC Research August 2011 - August 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" June 2010 - July 2011
Quintiles November 2008 - June 2010
PAREXEL January 2007 - November 2008
Westat 2006 - 2007
Duke Clinical Research Institute 1997 - 2001
Skills
Oracle Clinical, EDC, GCP, Clinical Data Management, Inform, CDISC, Clinical Trials, Data Management, CRO, CTMS, Medidata, ICH-GCP, CRF design, Biostatistics, SDTM
Education
North Carolina Central University 2002 — 2005
Health Education
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" August 2010 - Present
Bausch & Lomb January 2003 - Present
eReady Monitors November 2007 - February 2008
PTC Therapeutics 2005 - 2008
Skills
CRO, CTMS, GCP, Oncology, Ophthalmology, Pharmacovigilance, Clinical Trials, Clinical Monitoring, FDA, EDC, Pharmaceutical Industry, Drug Development, Protocol writing, Clinical SOPs, Clinical Research, Therapeutic Areas, Clinical Data Management, ICH-GCP, Protocol, Clinical Development, Inform, Infectious Diseases, Clinical Operations, Medical Writing, Regulatory Affairs
Education
University of North Carolina at Chapel Hill
MS, Bacteriology, Immunology
CoreSite February 2014 - Present
CoreSite December 2012 - February 2014
CoreSite August 2011 - December 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" August 2010 - August 2011
OSI Pharmaceuticals March 2005 - September 2010
eCollege.com January 2004 - March 2005
Skills
Disaster Recovery, Active Directory, VMware, Troubleshooting, Cisco Technologies, Microsoft Exchange, Security, Hardware, Technical Support, Blackberry Enterprise..., Software Installation, Windows, Storage, Laptops, Help Desk Support, System Deployment, Hyper-V, Printers, LAN-WAN, Databases, Data Center, TCP/IP, Virtualization, VPN
Education
Colorado State University 1997 — 2001
Computer Information Systems, Business
Social & Scientific Systems July 2013 - Present
SRA International September 2010 - Present
Family Health International January 2009 - September 2010
fhi January 2009 - September 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2010 - June 2010
North Carolina Institute for Public Health May 2008 - January 2009
SRA International, formerly Constella Group, LLC September 2006 - August 2007
Family Health International September 2005 - September 2006
United States Peace Corps January 2003 - April 2005
Skills
Public Health, Clinical Trials, Clinical Research, Qualitative Research, Data Management, Research, Software Documentation, Epidemiology, Analysis, Project Management
Education
The George Washington University School of Medicine and Health Sciences 2010 — 2014
MSHS, Clinical Research Administration
University of North Carolina at Chapel Hill 2007 — 2009
MPH, Public Health
University of California, Santa Cruz 1997 — 2001
BA, French
Merz North America, Inc. September 2012 - Present
ClinDev Consulting, LLC 2001 - Present
Otsuka Pharmaceutical Development and Commercialization March 2011 - August 2012
Cardioxyl Pharmaceuticals December 2009 - March 2011
BioCryst Pharmaceuticals 2009 - 2009
Roche Kforce Alliance 2005 - 2008
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2004 - 2005
Family Health International 2002 - 2005
Triangle Pharmaceuticals 1998 - 2002
ClinTrials Research 1996 - 1998
Skills
Clinical Research, Clinical Trials, Clinical Trial..., Clinical Development, SOP, Protocol Development, Cardiology, Infectious Diseases, Medical Devices, CTMS, Clinical Monitoring, Clinical Study Design, CRO, Vaccines, Pharmaceutical Industry, Oncology, Drug Development, ICH-GCP, EDC, GCP, Therapeutic Areas, Regulatory Affairs, Regulatory Submissions, FDA, Protocol, Clinical Data Management, 21 CFR Part 11, Diabetes
Education
Pfeiffer University 1995 — 1998
MBA, MHA, Business and Health Administration
Guilford Technical Community College
AAS, Dental Hygiene
High Point University
BA, Industrial Organization Psychology
Dixon Hughes Goodman LLP June 2010 - August 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" June 2009 - April 2010
PPD June 2007 - June 2009
Education
North Carolina State University - College of Management 2010 — 2011
Masters of Accounting
North Carolina State University - College of Management 2007 — 2009
BS - Cum Laude - Business Management, Finance and Accounting
Methodist University 2005 — 2007
Finance and Accounting
inVentiv Health Clinical November 2014 - Present
inVentiv Health Clinical November 2014 - Present
FHI 360 June 2014 - September 2014
Family Health International 360 February 2009 - May 2014
inventiv health clinical 2014 - 2014
inventiv health clinical 2014 - 2014
inventiv health clinical 2014 - 2014
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2010 - May 2011
Polaris Compliance Consultants, Inc "formerly known as Polaris Clinical Research Consultants" May 2008 - November 2008
Health Decisions 2008 - 2008
Skills
Clinical Trials, Clinical Data Management, Clinical Research, Sop, FDA, GCP, 21 CFR Part 11, Cross-functional Team..., Clinical Study Design, Data Management, Regulatory Affairs, Biotechnology, CTMS, Oncology, Clinical Monitoring, SOP
Education
Society of Clinical Research Associates 2008 — 2015
Certificate, Clinical Research - CCRP -
Durham Technical Community College 2006 — 2008
A.A.S, Clinical Trial Reseach Associate
California Polytechnic State University-San Luis Obispo 1995 — 1999
BS, Computer Engineering
Le Hong Phong Highschool
Duke Clinical Research Institute October 2010 - Present
UCB Pharma 2010 - 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2009 - 2010
Quintiles 2006 - 2009
PPD 2006 - 2006
Skills
Inform, EDC, GCP, Therapeutic areas, Clinical Research, Regulatory Reporting, Drug Safety, Medidata, SharePoint, Clintrace, Oracle AERS, ARISg, Intralinks, Share Web, Clinical Trials, Clinical Events..., MS Office Suite
Education
North Carolina Agricultural and Technical State University 2001 — 2005
Bachelors of Art, English
Southeast Raleigh High School
Southeast Raleigh High School
PPD July 2013 - Present
Novella Clinical December 2011 - July 2013
Novella Clinical, Inc. February 2011 - December 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" October 2005 - February 2011
PPD 2001 - 2005
PPD 1999 - 2001
PPD 1990 - 1998
Skills
Clinical Research, Leadership, FDA, CTMS, Clinical Monitoring, EDC, Clinical Trials, Project Management, Clinical Development, CRO, Training, Vaccines, GCP, Therapeutic Areas, Clinical Operations, ICH-GCP, Oncology
Education
University of North Carolina at Wilmington 1984 — 1988
BS, Biology
INC Research June 2015 - Present
INC Research February 2014 - May 2015
Quintiles July 2012 - February 2014
Quintiles January 2012 - July 2012
Novella Clinical, Inc. January 2011 - January 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" March 2010 - January 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2010 - March 2010
Healthwise Pharmacy September 2008 - November 2009
Skills
CTMS, Therapeutic Area, Clinical Trials, Multiple Myeloma, Infectious Diseases, Analysis, CRO, Clinical Development, Clinical Data Management, Clinical Research, Clinical Operations, Clinical Monitoring, EDC, Clinical Study Design, ICH-GCP, GCP, Management, IRB, Pharmaceutical Industry, Oncology, Project Management, Software Documentation, Therapeutic Areas
Education
East Carolina University 2006 — 2010
BS, Health Services Management
PPD September 2014 - Present
DST Health Solutions April 2014 - September 2014
Novella Clinical, Inc. April 2013 - April 2014
Novella Clinical, Inc. March 2011 - April 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" October 2010 - March 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" April 2009 - October 2010
RTI Health Solutions April 2007 - April 2009
Skills
Clinical Trials, CTMS, GCP, EDC, CRO, Clinical Development, Oncology, Clinical Research, ICH-GCP, Pharmaceutical Industry, Inform, Sop, Infectious Diseases, Regulatory Affairs, Pharmacovigilance, Cardiology, Diabetes, Biotechnology, Clinical Operations, Medical Devices, Vaccines, Drug Safety, 21 CFR Part 11, Drug Development, Regulatory Requirements, Gastroenterology, FDA, Protocol
Education
The George Washington University School of Medicine and Health Sciences 2009 — 2011
MSHS, Clinical Research
William & Mary 1998 — 2002
BA, Anthropology, History
Quintiles January 2015 - Present
Quintiles March 2013 - Present
Quintiles March 2011 - Present
Quintiles March 2009 - March 2011
Quintiles January 2006 - March 2009
Quintiles December 2003 - December 2006
Verispan January 2003 - December 2003
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" September 2002 - December 2002
Quintiles September 2000 - September 2002
Quintiles January 1999 - September 2000
Skills
Account Management, Business Development, Intranet, Marketing, Cold Calling, Lead Generation, CRO, Metadata Management, Clinical Trials, Laboratory, Business Communications, Project Management, Project Planning, Problem Solving, Collaboration, Proposal Writing, Proposal Generation, Proposal Support, Sales Operations, Salesforce.com, Microsoft Office, Clinical Research, Cross-functional..., Closing Deals, Closing Business, Clinical Monitoring, Oncology, CTMS, ICH-GCP, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry, EDC, Biotechnology, Clinical Development, Cross-functional Team..., GCP, Cardiology, FDA, Biopharmaceuticals, Deal Closure, Life Sciences, Management, Drug Development, SOP, Infectious Diseases
Education
North Carolina State University 1992 — 1996
Forest Management, Forestry, Natural Resources, Mapping
Sanderson Highschool 1988 — 1992
Diploma, Popularity and Band Camp
Quintiles October 2014 - Present
Quintiles June 2012 - October 2014
Novella Clinical, Inc. May 2011 - May 2012
i3 Research February 2011 - May 2011
i3 Research August 2009 - February 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" August 2008 - August 2009
i3 Research August 2007 - August 2008
PPD January 2005 - August 2007
Integrated Laboratory Systems January 2004 - January 2005
Skills
Clinical Trials, CRO, GCP, CTMS, Pharmaceutical Industry, Clinical Development, EDC, ICH-GCP, Oncology, Regulatory Affairs
Education
Durham Technical Community College 2004 — 2005
Certificate, Clinical Research
Greensboro College 1999 — 2003
BS, Biology, Chemistry, Religion
Drug Safety Navigator, LLC January 2015 - Present
Five Oaks Pharm, LLC September 2011 - January 2015
Inspire May 2010 - September 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2009 - May 2010
UCB Pharma 2007 - 2009
Drug Safety Alliance July 2006 - September 2007
PPD 2002 - 2006
Skills
Clinical Trials, CRO, Clinical Research, Pharmacovigilance, ICH-GCP, Drug Safety, EDC, Sop, CTMS, Pharmaceutics, Biotechnology, Regulatory Requirements, Oncology, Clinical Development, GCP, SOP
Education
University of Michigan 1982 — 1986
BSN, Nursing
The EMMES Corporation November 2010 - August 2011
Clinical PRofessionals Network 2009 - 2011
Clinsys Clinical Research March 2008 - March 2010
COVANCE INCORPORATED March 2007 - February 2008
Kendle International December 2005 - February 2007
Chiltern International June 2004 - November 2005
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" June 2003 - June 2004
Phoenix Data Systems October 2002 - June 2003
Bayer CropScience March 2002 - October 2002
PAREXEL - CONTRACT December 2000 - February 2002
Education
Villanova University
UNIVERSITY OF NORTH CAROLINA
North Carolina Central University 1987 — 1991
B.A., Political Science (minor) Life Sciences
United Therapeutics September 2013 - Present
United Therapeutics September 2012 - September 2013
Drug Safety Alliance October 2011 - September 2012
United Therapeutics November 2010 - May 2011
Otsuka America Pharmaceutical, Inc. 2011 - 2011
Abbott Laboratories 2011 - 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2009 - November 2010
Synteract, Inc. 2008 - 2009
Quintiles 2006 - 2008
Duke University August 1998 - 2006
Skills
GCP, Clinical Research, Healthcare, Drug Safety, Clinical Trials, Oncology, CRO, Cardiology, EDC, Pharmacovigilance, Medical Devices, Research, Protocol, Sop, Nursing, Cancer, ICH-GCP, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, FDA, Medicine, Pharmaceutical Industry, Regulatory Requirements, Therapeutic Areas, SOP
Education
North Carolina Agricultural and Technical State University
BS, Nursing
ICON plc August 2013 - Present
UCB Pharma 2012 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2011 - March 2012
PPD 2001 - December 2010
Skills
Alternative Medicine, Yoga, Clinical Research, Oncology, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Trials, Diabetes, EDC, Holistic Health, Medicine, Nutrition, Wellness
Education
American College of Health Care Sciences 2010 — 2014
MS-CAM, Complementary Alternative Medicine
East Carolina University
BSN, Nursing
inVentiv Health August 2014 - Present
Quintiles Transnational January 2011 - August 2014
Quintiles Transnational January 2011 - February 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" October 2007 - December 2010
Resolvit February 2007 - October 2007
Skills
CRO, CTMS, Clinical Research, Clinical Trials, Digital Strategy, GCP, ICH-GCP
Education
East Carolina University 1994 — 1999
BS & MS, Child Development and Family Relations
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" September 2010 - Present
PPD August 2004 - December 2010
Integrated Pharma Services (IPS) August 2001 - May 2004
Pfizer January 2000 - May 2000
LabCorp February 1996 - July 1996
Skills
Clinical Trials, Rheumatoid Arthritis, Hypertension, Osteoporosis, EDC, CRO, Clinical Data Management, GCP, CTMS, Oracle Clinical, ICH-GCP, Breast Cancer, Inform, Clinical Development, Oncology, Clinical Research
Education
University of North Carolina at Chapel Hill
Bachelor of Applied Science (B.A.Sc.), Biology
MoonRidge Clinical Consulting January 2000 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2005 - 2011
Stamm Consulting November 1994 - December 1999
Skills
Oncology, Clinical Development, CTMS, Clinical Research, GCP, Pharmaceutical Industry, Therapeutic Areas, Project Management, CRO, Clinical Trials, Cell, EDC, Osteoporosis, Clinical Monitoring
Education
University of Phoenix 1989 — 1991
BSN, Nursing
University of Colorado Anschutz Medical Campus 1984 — 1985
Certificate, Womens' Health Care Nurse Practitioner
University of Nebraska-Lincoln 1978 — 1980
ADN, Nursing
Consulting January 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" December 2010 - April 2011
GlaxoSmithKline October 2009 - April 2010
The Durham News March 2009 - August 2009
GlaxoSmithKline March 2007 - February 2008
[Personal Time Away from Work] June 2005 - April 2007
GlaxoSmithKline June 2001 - June 2005
GlaxoSmithKline June 2001 - June 2005
Skills
Strategic Communications, Internal Communications, Pharmaceutical Industry, Change Management, Strategic Planning, Crisis Communications, Corporate Communications, Communications Planning, Program Management, Therapeutic Areas, Software Documentation, Technical Writing, Leadership, Strategy, Cross-functional Team...
Education
North Carolina State University
BA
The College of William and Mary
MA
Hapa Consulting Inc April 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" March 2009 - May 2011
Prologue Research January 2005 - January 2009
PRA International 2003 - 2004
Skills
EDC, Oncology, Inform, Clinical Monitoring, CTMS, Clinical Data Management
Education
Southwest Baptist University 1993 — 1998
Bachelor of Science (BS), Biology, General
Southwest Baptist University
Master of Science (MS), Health/Health Care Administration/Management
UNC Health Care August 2013 - Present
UCB November 2010 - July 2013
UNC Health Care June 2009 - November 2010
Duke University Medical Center October 2005 - March 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" October 2007 - June 2009
Quintiles November 2006 - October 2007
Hospital of the University of Pennsylvania July 2004 - October 2005
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, GCP, Medicine, Oncology, Clinical Data Management, ICH-GCP, Cardiology, Clinical Development, Therapeutic Areas, Pharmaceutical Industry, Infectious Diseases, Regulatory Submissions, Biotechnology, Medical Devices, Inform, Lifesciences
Education
Georgetown University 2015 — 2017
MSN, Acute Care Nurse Practitioner
Cedar Crest College 2000 — 2004
BS, Nursing
Worldwide Clinical Trials, Inc. December 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" September 2007 - November 2011
Novella Clinical 2007 - November 2011
PharmaLinkFHI March 2008 - January 2009
Skills
GCP, Clinical Trials, Oncology, Clinical Research, CTMS
Education
University of North Carolina at Wilmington 1984 — 1990
BA, Psychology
Whiteville High School 1980 — 1984
Novella Clinical, Inc. June 2010 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" September 2008 - April 2011
PharmaLinkFHI (now Novella Clinical) April 2006 - September 2008
Education
Millsaps College 1986 — 1990
Bracket January 2012 - Present
United BioSource Corporation August 2010 - January 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2010 - August 2010
Clinsys Clinical Research May 2008 - January 2010
INC Research May 2004 - April 2008
INC Research June 2003 - April 2004
Skills
Oracle Clinical, Clinical Trials, Clinical Research, EDC, Medidata, SAS, Clinical Data Management, Microsoft Office, CRO, Data Management, CDISC
Education
North Carolina State University 1999 — 2013
Bachelor's degree, Computer Science
North Carolina State University 1999 — 2003
Bachelor of Science (BS), Computer Science
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2009 - Present
Skills
Software Documentation, Active Directory, Troubleshooting, Cisco Technologies, VPN
Education
North Carolina State University 1995 — 1999
B.S., Microbiology
Self-Employed January 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2009 - December 2010
Kokes Research Consulting, LLC 1996 - 2009
Education
California State University, Fresno 1975 — 1978
BSN, nursing
from Clinical Research April 2010 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" September 2009 - February 2010
i3 Research October 2004 - June 2008
i3 Research July 2004 - October 2004
Mylan Bertek Pharmaceuticals 2002 - 2003
InSite Clinical Trials 1996 - 1997
Centrex Laboratories/ St Lukes Hospital August 1972 - September 1996
Skills
Clinical Trials, Regulatory Affairs, Clinical Research, Oracle Clinical, Management, Project Management, Drug Safety, GCP, Clinical Research..., CRO, CTMS, Clinical Development, Regulatory Submissions, ICH-GCP, EDC, FDA, Pharmaceutical Industry, Sop, Clinical Monitoring, Oncology, Infectious Diseases
Education
Wake Technical Community College 2009 — 2009
Career Latticing Series
State University of New York College at Buffalo 1964 — 1968
BS, Medical Technology
ReSearch Pharmaceutical Services April 2014 - Present
Novella Clinical, Inc. September 2012 - April 2014
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" November 2009 - September 2012
Cadence Pharmaceuticals June 2005 - September 2009
Cadence Pharmaceuticals January 2007 - February 2009
Cadence Pharmaceuticals June 2005 - January 2007
Biogen Idec August 2004 - June 2005
Neurocrine Biosciences September 2002 - August 2004
Quintiles February 2002 - September 2002
Quintiles May 2000 - February 2002
Skills
Clinical Trials, CTMS, Clinical Development, Budgets, CRO, GCP, Clinical Monitoring, EDC, Clinical Research
Education
Kansas State University 1995 — 1997
BS Dietetics
The University of Kansas 1993 — 1995
Docs Global October 2012 - August 2013
PRA International May 2011 - August 2012
CRA Consultant January 2011 - May 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2008 - 2010
Merz Pharmaceuticals March 2007 - July 2008
MDS Pharma Services April 2006 - March 2007
Monitoring Force USA, Inc. June 2003 - October 2005
PPD September 2002 - 2003
Quintiles 1998 - September 2002
George Washington University Medical Center 1997 - 1998
Education
George Mason University 1985 — 1996
BS, Biology
Eastbury Comprehensive School-+
BS Biology; Ordinary/Advanced Level Exams - Oxford, Cambridge, London Universities, Chemistry, Biology, Physics, Maths, RE, English Language, English Literature, Sociology, Geography
Novella Clinical, Inc. November 2014 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" December 2007 - Present
Novella Clinical, Inc. December 2010 - April 2013
Cary Psychiatry March 2007 - December 2007
South East Regional Authority 2002 - 2007
Skills
CRO, EDC, CTMS, Security, Software Documentation, Customer Service, Customer Support, Active Directory, Exchange 2010/2007/2003, Knowledge Base, Remedy Ticketing System, Track-It, Oracle Clinical, Protocol, Clinical Data Management, Clinical Development, Clinical Trials
Education
DeVry Institute of Technology 1983 — 1985
Computer Science and Programming, Computer Science
College of Trades and Technology 1980 — 1981
Clerk Typist Diploma
Novella Clinical March 2010 - Present
Omnicare Clinical Research October 2006 - March 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2000 - 2006
Education
East Carolina University 1991 — 1994
Bachelor, Health Information Management
Louisburg College 1989 — 1991
Associates
FHI 360 October 2014 - Present
FHI 360 April 2012 - Present
FHI 360 January 2010 - April 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" August 2006 - July 2007
Skills
Human Resources, Onboarding, HRIS, Performance Management, HR Policies, Training, Personnel Management, Nonprofits, Taleo
Education
Southeastern Baptist Theological Seminary 2007 — 2011
Biblical Counseling
Appalachian State University 2002 — 2006
BS, Psychology
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2010 - 2010
GTC Biotherapeutics 1996 - 2008
Genzyme 1992 - 2001
Skills
Clinical Trials, GCP, Biotechnology, Clinical Development, Drug Development, Pharmaceutical Industry, FDA, Clinical Research, CRO
Education
Duke University, NC 2010 — 2010
Certificate in Legal Nurse Consutling, Medical Malpractice & Pharmaceutical Litigation, No grade given; LNC Certificate
Roosevelt Hospital School of Nurse Anesthesia 1974 — 1976
Certified Registered Nurse Anesthetist, Clinical Anesthesia
University of Miami - School of Nursing 1964 — 1968
BSN, Registered Nursing/Registered Nurse
Duke University
Certificate, Legal Nurse Consulting
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" April 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2007 - Present
Education
The Ohio State University 1992 — 1994
The Ohio State University 1985 — 1986
arrowpoin solution inc 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2000 - 2001
Education
Hardin-Simmons University 1988 — 1997
computer's engineering, computer scientist
Weber State University 1988 — 1989
enginner, enginnering
PAREXEL June 2011 - Present
PAREXEL June 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" December 2008 - May 2011
Skills
GCP, CRO, Oncology, CTMS, Clinical Data Management, Clinical Trials, Clinical Development, Inform, EDC, Clinical Monitoring, Sop, ICH-GCP, Pharmaceutical Industry, Oracle Clinical
Education
North Carolina State University 2000 — 2004
Bachelor's degree, Biology/Biological Sciences, General
INC Research 2015 - Present
Theorem Clinical Research November 2014 - July 2015
HealthCare Connexions, a Telerx Company (a wholly owned subsidiary of Merck) July 2014 - October 2014
HealthCare Connexions, A Telerx Company (wholly owned subsidiary of Merck) March 2013 - July 2014
PAREXEL April 2010 - March 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" December 2007 - March 2010
PPD March 2007 - December 2007
Southeastern Reproductive Health March 2006 - April 2007
Access Nurses August 2006 - February 2007
CaroMont Health October 2000 - July 2006
Skills
Pharmacovigilance, Drug Safety, GCP, Clinical Trials, ICH-GCP, CRO, MedDRA, EDC, Clinical Development, Oncology, Therapeutic Areas, Regulatory Submissions, ARISg, Inform, Medical Affairs, Regulatory Affairs, Infectious Diseases, Drug Development, SAE Reconciliation, Protocol, 21 CFR Part 11, Cardiology, Argus Safety, Regulatory Requirements, Neurology, FDA, Adverse Event Reporting, Hematology, Diabetes, Clinical Operations, Medidata, Endocrinology, Gastroenterology, Biotechnology, Pharmaceutics, Lifesciences, Oracle Clinical, CRF design, Phase I, Pharmacology, Cancer, Oncology Clinical..., IRB, ICH guidelines, Pharmaceutical Industry, Clinical Research, SOP
Education
Western Governors University 2012 — 2014
BSHIT, Health Care Informatics
University of Phoenix 2006 — 2008
MSN,MHA, Nursing, Health Care Administration
University of Phoenix 2005 — 2006
BSN, Nursing
Foothills Nursing Consortium 1996 — 1997
ADN, Nursing
Isothermal Community College 1990 — 1991
LPN, Nursing
Covance, Inc. February 2014 - December 2014
Covance February 2014 - November 2014
United Therapeutics April 2013 - August 2013
Onyx Pharmaceuticals October 2012 - March 2013
Otsuka America Pharmaceutical, Inc. August 2011 - March 2012
INC Research March 2010 - July 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" 2009 - 2010
Skills
ICH-GCP, Oncology, Clinical Development, Clinical Trials, Pharmacovigilance, CRO, Pharmaceutics, Protocol, Drug Safety, Regulatory Submissions, FDA, MedDRA, Sop, GCP, Clinical Research, Pharmaceutical Industry, CTMS, Regulatory Affairs, Biotechnology, Clinical Data Management, EDC, Medical Writing, Therapeutic Areas, Clinical Monitoring, Drug Development, Life Sciences, Infectious Diseases, Medical Devices, Medical Affairs, Cardiology, 21 CFR Part 11, Neurology
Education
Albert Einstein Medical Center School of Nursing 1982 — 1984
RN, Nursing
Lincoln University 1972 — 1976
BA, French/Education